| CTRI Number |
CTRI/2025/11/097701 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Vatapatradi Lepa With And Without Ksheeradhuma In The Management Of Acne |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Vatapatradi Lepa With And Without Ksheeradhuma In The Management Of Mukhadushika (Acne Vulgaris) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jigna Jayeshbhai Parmar |
| Designation |
PG Scholar |
| Affiliation |
G. J. Patel Institute Of Ayurvedic Studies And Research |
| Address |
Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120
Anand
GUJARAT
388120
India |
| Phone |
9081938418 |
| Fax |
|
| Email |
jignaparmar5354@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Gandhe |
| Designation |
Professor & HOD |
| Affiliation |
G. J. Patel Institute Of Ayurvedic Studies And Research |
| Address |
Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120
Anand
GUJARAT
388120
India |
| Phone |
9422062452 |
| Fax |
|
| Email |
gayatri.gandhe@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Gandhe |
| Designation |
Professor and HOD |
| Affiliation |
G. J. Patel Institute Of Ayurvedic Studies And Research |
| Address |
Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120
Anand
GUJARAT
388120
India |
| Phone |
9081938418 |
| Fax |
|
| Email |
gayatri.gandhe@cvmu.edu.in |
|
|
Source of Monetary or Material Support
|
| S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120 |
|
|
Primary Sponsor
|
| Name |
Dr Jigna Jayeshbhai Parmar |
| Address |
Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jigna Jayeshbhai Parmar |
S. G. Patel Ayurveda Hospital And Maternity Home |
Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120
Anand
GUJARAT |
9081938418
jignaparmar5354@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G. J. Patel Institute Of Ayurvedic Studies And Research, S. G. Patel Ayurveda Hospital and Maternity Home Institutional (Human) Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Ksheeradhuma | (Procedure Reference: Charaka Samhita Sutra Sthana Swedana Adhyaya 13th Chapter, Procedure details: SOP of Ksheeradhuma - The patient will be seated comfortably with head slightly bent in forward direction. The eye will be covered with a soft cotton pad soaked in water & bandage will be wrapped around head over eyes to prevent irritation. The steam from the medicated milk heated in a wide mouthed vessel directed towards face will be given for 2 to 5 min or till Swedapradurbhava. After Ksheeradhma, face will be wiped with a napkin &Vatapatradi Lepa prepared with water will be applied. Face will be cleaned by washing with water after about 70% of Vatapatradi Lepa gets dried.
)
(1) Medicine Name: Vatapatradi Lepa, Reference: Sharangdhara Samhita Madhyama Khanda 11/13-14, Route: Topical, Dosage Form: Lepa Churna, Dose: 7(g), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhara Samhita Madhyama Khanda 11/13-14, Procedure details: Patient will be asked to wash face with plain water & dry by patting.
Vatapatradi Lepa prepared in water will be applied evenly on face. Face will be cleaned by washing with water after about 70% of Vatapatradi Lepa gets dried.)
(1) Medicine Name: Vatapatradi Lepa, Reference: Sharangdhara Samhita Madhyama Khanda 11/13-14, Route: Topical, Dosage Form: Lepa Churna, Dose: 7(g), Frequency: od, Duration: 15 Days |
|
| Intervention |
Procedure Name :Vatapatradi lepa with ksheeradhuma |
Reference :Charak Samhita Sweda adhyay Details : The patient will be seated comfortably with head slightly bent in forward direction
The eye will be covered with a soft cotton pad soaked in water & bandage will be wrapped around head over eyes to prevent irritation The steam from the medicated milk heated in a wide mouthed vessel directed towards face will be given for 2 to 5 min or till Swedapradurbhava After Ksheeradhma, face will be wiped with a napkin &Vatapatradi Lepa prepared with water will be applied Face will be cleaned by washing with water after about 70% of Vatapatradi Lepa gets dried
|
| Comparator Agent |
VATAPATRADI LEPA |
Procedure Name: Vatapatradi lepa Reference: Sharangdhar Madhyamkhanda Route: Topical Dosage Form : Lepa Churna Dose:7 gm Details : Patient will be asked to wash face with plain water and dry by patting with napkin Vatapatradi Lepa prepared in water will be applied evenly on face and Face will be cleaned by washing with water after about 70% of Vatapatradi Lepa gets dried |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 to 35 years Patients fulfilling the criteria of Mukhadushika presenting with clinical symptoms like Pitika Ruja Raktima Kandu Patients willing to provide informed consent prior to initiation of the study procedure |
|
| ExclusionCriteria |
| Details |
Patients aged less than 18 years and more than 35 year Patients having other skin diseases like psoriasis atopic dermatitis skin tuberculosis leprosy etc Patients with a history of any drug allergies Patients with systemic illness and hormonal disorders like diabetes hypertension cardiac problem etc Patients taking steroid or hormonal therapy Patients having acne vulgaris other than face region like chest and back Patients who are not willing to give written consent Patients who have any immunosuppressive disease like HIV cancer or severe anemia |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the signs and symptoms of Mukhadushika (Acne Vulgaris) — i.e., reduction in symptoms such as Pidika (papules and pustules), Kandu (itching), Daha (burning), Srava (secretion/discharge), Paka (suppuration), Vedana (pain), Medogarbhatva (oily/greasy nature of lesion) assessed using a standardized gradation system for each symptom and the Global Acne Grading System (GAGS) as the objective parameter.
|
Day 1 – Before treatment (Baseline), Day 7 – After treatment, Day 15 – After treatment, Day 30 – Follow-up
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The proposed study titled A Comparative Clinical Study to Evaluate the Efficacy of Vatapatradi Lepa with and without Ksheeradhuma in the Management of Mukhadushika (Acne Vulgaris) aims to scientifically validate an Ayurvedic approach for acne management through external Panchakarma therapies. Mukhadushika, described under Kshudraroga by Acharya Sushruta, is a Kapha-Vata predominant disorder involving Rakta Dhatu, characterized by Pidika (papules and pustules) resembling Shalmali Kantaka. Modern acne vulgaris, a chronic inflammatory condition of the pilosebaceous unit, affects up to 90% of adolescents and has considerable psychological impact. Current modern treatments such as antibiotics, retinoids, and hormonal agents carry risks of side effects and recurrence, highlighting the need for safe and effective alternatives. In Ayurvedic practice, Lepa (herbal paste application) has proven useful, but the combined effect of Ksheeradhuma (medicated milk steam) and Vatapatradi Lepa remains unexplored. Ksheeradhuma is a type of Snigdha Nadi Sweda that helps liquefy morbid doshas, open skin pores, and facilitate deeper drug absorption, while Vatapatradi Lepa possesses Rakta Shodhaka, Twaka Prasadana, and Vata-Kaphahara properties beneficial in acne. This randomized comparative clinical trial will enroll 40 patients aged 18–30 years diagnosed with Mukhadushika. Participants will be divided into two groups Group A receiving Ksheeradhuma followed by Vatapatradi Lepa, and Group B receiving only Vatapatradi Lepa for 15 days. Assessment will be based on classical signs and symptoms (e.g., Pidika, Daha, Kandu, Srava, Shotha, Vaivarnya) and modern acne grading systems (GAGS). The study hypothesizes that the addition of Ksheeradhuma enhances the therapeutic efficacy of Vatapatradi Lepa by improving circulation, skin detoxification, and local drug penetration. The outcome is expected to offer a cost-effective, natural, and holistic Ayurvedic protocol for acne management, minimizing adverse effects while promoting Twaka Prasadana (healthy skin) and patient well-being. |